Risperidone

What it is and how it works

Mechanism of Action The mechanism of action of risperidone tablets, in schizophrenia, is unknown. However, it has been proposed that the drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism.The clinical effect from risperidone tablets results from the combined concentrations of risperidone and its major metabolite, 9-hydroxyrisperidone . Antagonism at receptors other than D 2 and 5HT 2 may explain some of the other effects of risperidone tablets.

Indications

Risperidone tablets are an atypical antipsychotic indicated for: • Treatment of schizophrenia • As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder • Treatment of irritability associated with autistic disorder Schizophrenia Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults . Bipolar Mania Monotherapy Risperidone tablets are indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) . Adjunctive Therapy Risperidone tablets adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults .

Dosage and administration (summary)

Table 1. Recommended Daily Dosage by Indication Initial Dose Titration (Increments) Target Dose Effective Dose Range Schizophrenia: adults 2 mg 1 to 2 mg 4 to 8 mg 4 to 16 mg Schizophrenia: adolescents 0.5 mg 0.5 to 1 mg 3 mg 1 to 6 mg Bipolar mania: adults 2 to 3 mg 1 mg 1 to 6 mg 1 to 6 mg Bipolar mania: children and adolescents 0.5 mg 0.5 to 1 mg 1 to 2.5 mg 1 to 6 mg Irritability in autistic disorder 0.25 mg Can increase to 0.5 mg by Day 4: (body weight less than 20 kg) 0.5 mg Can increase to 1 mg by Day 4: (body weight greater than or equal to 20 kg) After Day 4, at Interval of > 2 weeks: 0.25 mg (body weight less than 20 kg) 0.5 mg (body weight greater than or equal to 20 kg) 0.5 mg: (…

Contraindications

Risperidone tablets are contraindicated in patients with a known hypersensitivity to the risperidone tablets. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone. • Known hypersensitivity to risperidone tablets

Warnings and precautions

• Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis: Risperidone tablets are not approved for use in patients with dementia-related psychosis • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation of risperidone tablets and close monitoring. • Tardive dyskinesia: Consider discontinuing risperidone tablets if clinically indicated. • Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular / cerebrovascular risk.

Pregnancy

Pregnancy Pregnancy Category C. Risk Summary Adequate and well controlled studies with risperidone tablets have not been conducted in pregnant women. Neonates exposed to antipsychotic drugs (including risperidone tablets) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Storage and supply

How Supplied Risperidone Tablets Risperidone Tablets USP 1 mg are white to off white, circular, biconvex, film coated tablets, engraved with 'RI3' on one side and plain on other and are supplied as follows: Bottles of 30's NDC 63187-264-30 Storage and Handling Risperidone Tablets should be stored at 20° to 25°C (68° to 77°F).

Source: Risperidone (Risperidone) — US FDA prescribing information, 2022-10-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.